HealthyNCT03113864
Effects of Lutein on Visual Function
A study testing Lutein in people with Healthy and Nutrition Poor, run by Kemin Foods LC at 1 site in United Kingdom.
Trial summary
Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of interest is middle-aged men and women who have low levels of carotenoids in their eyes. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Nutrition Poor
- What is being tested?
- Lutein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women age 40-60 years
- Corrected Visual Acuity of 20/20 to 20/25
- MPOD 0.05- 0.30 OD units
- Must be able to give written informed consent in English
- BMI < or = 30 kg/m2
- Subject is willing to maintain a habitual diet and physical activity patterns throughout the study period
Who cannot join
- Use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start)
- Ocular pathologies
- History of active small bowel disease or resection
- Uncontrolled hypertension
- Diabetes mellitus
- Pancreatic disease
Show all 18Show fewer
- Pregnancy (or planning to become pregnant) or lactation
- Diseases that interfere with fat absorption
- Medication or supplements that contain a significant level of carotenoids
- Medications that interfere with fat absorption
- Use of drugs suspected of interfering with metabolism of blood clotting
- Chronic alcohol intake
- Stroke, head injury with loss of consciousness or seizures
- Severe Amblyopia resulting in visual acuity worse than 0.4 MAR
- Subject is a heavy smoker (> 1 pack/day)
- A regular consumer of lutein rich foods or lutein supplements
- A regular consumer of foods high in DHA intake or DHA supplements
- Subject has donated more than 300 mL of blood during the last three months prior to screening
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Manchester
Manchester, United Kindgom, M13 9PL
About this study
Official title: Beneficial Effects of Lutein on Visual Function in Healthy Subjects
Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of interest is middle-aged men and women who have low levels of carotenoids in their eyes.
Read the detailed description
The participants will be given a brief explanation of the study and asked to sign an informed consent form. During the screening visit, pre-study parameters will be measured in order to assess the subjects' eligibility to participate.
These include:
- Medical History
- Vital signs, Height and weight and BMI calculation
- Visual Parameters
- Blood draw for clinical chemistry and hematological safety
Intervention Period:
At baseline visual parameters and a serum sample for analysis of inflammatory markers will be taken. Supplements will be dispensed. Study visits will then be conducted every 3 months. At these visits, subjects will have visual parameters, adverse events, study diary, vitals, a questionnaire evaluating health/diet/exercise/alcohol, product distribution and compliance checked. A final serum/plasma sample will be taken at the final visit for re-assessment of safety parameters and inflammatory markers.
Compliance check:
The number of tablets dispensed at baseline and returned, as well as all intake information from a subject diary. Per protocol population is defined apriori as >80%.
- Conditions
- Healthy, Nutrition Poor
- Being tested
- Placebo, Lutein
- Keywords
- Vision, Eye Health, Lutein, Carotenoids
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Daily supplementation for 9 months
LuteinDietary supplement
Daily Supplementation for 9 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Will be identical looking to treatment Receives: Dietary Supplement: Placebo |
| Lutein | Experimental | 10 mg of FloraGLO Lutein Receives: Dietary Supplement: Lutein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary outcome: Cone Sensitivity Recovery
Visual Parameter
Measured: 9 months
Co-primary outcome: Chromatic Contrast Sensitivity
Visual Parameter
Measured: 9 months
Secondary outcomes (5)
Dark Adaption
Visual Parameter
Measured: 9 months
Macular Pigment Optical Density
Visual Parameter
Measured: 9 months
Visual Acuity
Visual Parameter
Measured: 9 months
Complement Factor D, C5a, and MAC
Inflammatory Marker
Measured: 9 months
Plasma Carotenoid Levels
Blood Marker
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Apr 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: Recruiting Issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kemin Foods LC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113864
- Sponsor's protocol ID
- 16-004
- Status last verified
- Apr 2017
- First submitted
- 15 Mar 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Lutein on Visual Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03113864
- Acronym / sponsor ID
- 16-004
- Conditions
- Healthy, Nutrition Poor
- Keywords
- Vision, Eye Health, Lutein, Carotenoids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting Issue
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kemin Foods LCIndustry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of interest is middle-aged men and women who have low levels of carotenoids in their eyes.
Detailed description
The participants will be given a brief explanation of the study and asked to sign an informed consent form. During the screening visit, pre-study parameters will be measured in order to assess the subjects' eligibility to participate.
These include:
- Medical History
- Vital signs, Height and weight and BMI calculation
- Visual Parameters
- Blood draw for clinical chemistry and hematological safety
Intervention Period:
At baseline visual parameters and a serum sample for analysis of inflammatory markers will be taken. Supplements will be dispensed. Study visits will then be conducted every 3 months. At these visits, subjects will have visual parameters, adverse events, study diary, vitals, a questionnaire evaluating health/diet/exercise/alcohol, product distribution and compliance checked. A final serum/plasma sample will be taken at the final visit for re-assessment of safety parameters and inflammatory markers.
Compliance check:
The number of tablets dispensed at baseline and returned, as well as all intake information from a subject diary. Per protocol population is defined apriori as >80%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboWill be identical looking to treatment |
| Lutein | Experimental | Dietary Supplement: Lutein10 mg of FloraGLO Lutein |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women age 40-60 years
- Corrected Visual Acuity of 20/20 to 20/25
- MPOD 0.05- 0.30 OD units
- Must be able to give written informed consent in English
- BMI < or = 30 kg/m2
Key exclusion criteria (18 listed)
- Use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start)
- Ocular pathologies
- History of active small bowel disease or resection
- Uncontrolled hypertension
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDaily supplementation for 9 months | Dietary supplement | Placebo |
| LuteinDaily Supplementation for 9 months | Dietary supplement | Lutein |
Primary outcome
Co-primary outcome: Cone Sensitivity Recovery
Time frame: 9 months
Visual Parameter
Co-primary outcome: Chromatic Contrast Sensitivity
Time frame: 9 months
Visual Parameter
5 secondary outcomes
Dark Adaption
Time frame: 9 months
Macular Pigment Optical Density
Time frame: 9 months
Visual Acuity
Time frame: 9 months
Complement Factor D, C5a, and MAC
Time frame: 9 months
Plasma Carotenoid Levels
Time frame: 9 months
Results and safety
The study was stopped early (reason given: Recruiting Issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein in people with Healthy and Nutrition Poor, run by Kemin Foods LC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting Issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary outcome: Cone Sensitivity Recovery (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.